Toulouse, France, January 16, 2025 – The long-term partnership between Cell-Easy and Toulouse University Hospital (CHU Toulouse) continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator Dr Etienne Buscail, a colo-rectal surgeon and proctologist at Toulouse University Hospital, recently submitted a request for authorization of CTA to the European Agency EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1. [Read more…]
Nucleus Biologics Becomes First Custom Cell Culture Media Company to Achieve EXCiPACT Certification for the Manufacture of Excipient GMP Quality Cell Culture Media, Supplements, and Buffers
San Diego, CA, January 9, 2025 – Nucleus Biologics, a leader in precision cell culture media development, is proud to announce that it has achieved an industry-leading quality milestone. It has received EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification from SGS. This Excipient GMP certification will better support the cell culture media, buffers, reagents, and supplements needs for our cell and gene therapy customers. This certification, in addition to our ISO 13485 certification, underscores Nucleus Biologics’ commitment to delivering the highest quality products that meet the most stringent safety, consistency, and compliance requirements of the biopharmaceutical industry. [Read more…]
I Peace manufactures 100 lines of GMP iPS Cells cumulatively
Proof of customer recognition of its quality and mass manufacturing capability
Palo Alto, CA, January 7, 2025 — Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the number of GMP-grade iPS cells manufactured has reached 100 lines. This achievement solidifies I Peace as a true leader in the realm of iPS cell manufacturers, equipped with abundant experience in manufacturing GMP-grade iPS cells in compliance with global regulations. [Read more…]
Tolerance Bio Announces Scientific Advisory Board and $20.2M Seed Round to Advance Thymus-Based Therapies for Immune-Mediated Diseases
World-class leaders in the thymus, immunology, oncology, cell therapy, and drug development will inform and support the Company’s efforts to preserve, restore, and manipulate the thymus to address immune diseases
Pacific 8 Ventures joined the seed round syndicate led by Columbus Venture Partners, with participation by Criteria Bio Ventures, Sessa Capital, BioAdvance, and Ben Franklin Technology Partners
PHILADELPHIA, December 19, 2024 –Tolerance Bio, Inc., a biopharma company pioneering innovative approaches to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, today announced the formation of its Scientific Advisory Board (SAB) and the completion of its oversubscribed $20.2M seed financing round. [Read more…]
Axol Bioscience Secures SMART Grant to Accelerate the Development of a Commercial iPSC-Powered ALS Models
Axol Bioscience has been awarded a SMART Grant by Scottish Enterprise to Accelerate ALS Research through the development of ALS-related phenotypes using human iPSCs. This represents another significant step towards better disease modelling and ALS drug discovery.
The key objectives of this project are to:
- Develop a quality manufacturing system for iPSC-derived ALS relevant cell types
- Characterise and validate the cells using ALS relevant end points; TDP43 aggregation, Neurofilament Light elevation and Cryptic Exon Sequencing
- Develop and characterise an ALS co-culture model which includes motor neurons, microglia and astrocytes
- Commercialise an easy-to-use model system to drive forward ALS drug discovery
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